• Ayush Manufacturing License.
• Ayush Loan License.
• Contract Manufacturing / Third party manufacturing / Product to Product manufacturing.

Ayush Manufacturing License

If applicant wishes to obtain the license, for manufacturing and marketing, both products then the manufacturer must set up his own manufacturing unit. The basic requirements for obtaining AYUSH Manufacturing License

• The manufacturing unit should belong to industrial area.
• For one category of the drug only, the minimum space required is size of 1200 sq-ft
• One needs to add more space in case more than one drug is required, and to add more categories.
• The manufacturing unit should belong to industrial area.
• Minimum of 2 Ayurvedic experts and 2 Pharmacies must be part of the team.
• All the manufacturing and packaging machinery must be available with you.
• Drug Inspectors shall do regular inspection of the premise.

Ayush Loan License

For Ayush Loan Licence, the manufacturing unit is not owned by the applicant. The products are manufactured by the third-party manufacturers. For such Loan license is to apply with a GMP certified manufacturer and thereafter it will be issued to the applicant company. Thereafter the product approval is required to be obtained from the authorities. The Loan License holder can provide the raw materials and packaging material, or manufacturer can arrange it from own sources also. The manufacturer converts such raw material into finished products and thereafter provides the finished product.

Basic Requirement for obtaining AYUSH Loan License

• The manufacturing belongs to an industrial area.
• The premise should have minimum three rooms as per the description as given below:
1. One room for raw material storage;
2. One for storage of finished material and
3. One for office
• One should do Renewal of Loan License regularly
• It is must for Drug inspectors to visit on regular basis for inspection of premises.
• There is no need of Ayurvedic experts and Pharmacist.
• The company registration and the manufacturing set up must be the same.

Ayush Contract / Third-Party Manufacturing License>

In Ayush Contracts neither the person has the license nor has the manufacturing set of his own, only the marketing part is done by the third party, in that case, all compliance and liaison work shall be taken care by the manufacturer. The manufacturing license of the manufacturer shall be used; the manufacturer will have to get approval for your product from the concerned authorities. The Product shall display that the product is manufactured by the XYZ manufacturer and marketed by you.

Good manufacturing practice (GMP) is a system whereby it is ensured that the products are consistently produced and controlled according to quality standards as prescribed in line with the WHO. The intent behind such certification is to minimize the risks involved in any pharmaceutical production. The COPP (Certificate of a Pharmaceutical Product) is the legal document that certifies that the manufacturing company having this certificate is legally allowed to sell their pharmaceutical product in the country they are producing.